What are the responsibilities and job description for the Senior Formulations Scientist - Chemistry Manufacturing Controls position at Eurofins?
Company Description
Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.
The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. It also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products.
In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.
Job Description
Position Overview:
Provide strategic, tactical, and operational support to expedite the development of clinical trial portfolios by developing regulatory strategies and submissions.
Job Responsibilities:
- Lead preparation, review, and finalization of CMC sections for global CTA submissions.
- Critically review molecule-specific GRA-CMC development strategies and submission content.
- Make technical decisions on CMC regulatory issues with guidance from Client GRA-CMC regulatory scientists.
- Provide clear regulatory advice to CMC teams.
- Evaluate regulatory impact on CMC development plans.
- Communicate effectively within GRA-CMC and with the CMC development team.
- Partner with Client GRA-CMC regulatory scientists to develop complex regulatory strategies.
- Collaborate with Client RDE regulatory associates to complete submission activities.
Qualifications
Minimum Qualifications:
- Education: Bachelor's degree in a science discipline (e.g., chemistry, biology, biochemistry).
- Experience: 3-5 years in R&D or formulation roles focused on large molecule/biologics drug development.
- Industry Experience: Experience in CMC technical drug development (analytical development or formulation).
Additional Information
- Position is full-time, workingMonday-Friday 8:00 a.m.-5:00 p.m with overtime as needed
- Candidates currently living within a commutable distance of Indianapolis, IN are encouraged to apply.
- Excellent full-time benefits including comprehensive medical coverage, dental, and vision options
- Life and disability insurance
- 401(k) with company match
- Paid vacation and holidays
- #LI-EB1
Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.
